Robot Assisted Virtual Rehabilitation for the Hand Post Stroke (RAVR) (RAVR)

October 1, 2024 updated by: Sergei V. Adamovich PhD, New Jersey Institute of Technology

Optimizing Hand Rehabilitation Post Stroke Using Interactive Virtual Environments

This study investigates the effects of intensive, high dosage task and impairment based training of the hemiparetic hand, using haptic robots integrated with complex gaming and virtual reality simulations. There is a time-limited period of post-ischemic heightened neuronal plasticity during which intensive training may optimally affect the recovery of motor skills, indicating that the timing of rehabilitation is as important as the dosing. However, recent literature indicates a controversy regarding both the value of intensive, high dosage as well as the optimal timing for therapy in the first two months after stroke. This study is designed to empirically investigate this controversy. It is evident that providing additional, intensive therapy during the acute rehabilitation stay is more complicated to implement and difficult for patients to tolerate, than initiating it in the outpatient setting, immediately after discharge. The robotic/VR system is specifically designed to deliver hand and arm training when motion and strength are limited, using adaptive algorithms to drive individual finger movement, gain adaptation and workspace modification to increase finger and arm range of motion, and haptic and visual feedback from mirrored movements to reinforce motor networks in the lesioned hemisphere.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study investigates the effects of high dosage task and impairment based training of the hemiparetic hand, using haptic robots integrated with complex gaming and virtual reality simulations on recovery and function of the hand, when the training is initiated within early period of heightened plasticity. The intervention uses two training systems. NJIT-RAVR consists of a data glove combined with the Haptic Master robot that provides tracking of movements in a 3D workspace and enables programmable haptic effects, such as variable anti-gravity support, springs and dampers, and various haptic objects. The NJIT-TrackGlove consists of a robotic hand exoskeleton to provide haptic effects or assistance and an instrumented glove for finger angle tracking, and an arm tracking system to track hand and arm position and orientation. Using programmable software and custom bracing we enable use of this system for patients with a broad set of impairments and functional abilities. A library of custom-designed impairment and task-based simulations that train arm transport and hand manipulation, together or separately will be used. Pilot data show that it is possible to integrate intensive, high-dosage, targeted hand therapy into the routine of an acute rehabilitation setting. The study integrates the behavioral, the kinematic/kinetic and neurophysiological aspects of recovery to determine: 1) whether early intensive training focusing on the hand will result in a more functional hemiparetic arm; (2) whether it is necessary to initiate intensive hand therapy during the very early inpatient rehabilitation phase or will comparable outcomes be achieved if the therapy is initiated right after discharge, in the outpatient period; and 3) whether the effect of the early intervention observed at 6 months post stroke can be predicted by the cortical reorganization evaluated immediately prior to the therapy. This study will fill critical gaps in the literature and make a significant advancement in the investigation of putative interventions for recovery of hand function in patients post-stroke.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
115

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Saddle Brook, New Jersey, United States, 07663
        • Kessler Institute for Rehabilitation
      • West Orange, New Jersey, United States, 07052
        • Kessler Institute for Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • unilateral right or left sided stroke within 7 to 30 days of starting study
  • sufficient cognitive function to follow instructions
  • Fugl-Meyer (FM) of ≤ 49/66
  • intact cutaneous sensation (e.g. ability to detect <4.17 N stimulation using Semmes- Weinstein nylon filaments

Exclusion Criteria:

  • prior stroke with persistent motor impairment or other disabling neurologic condition
  • non-independent before stroke
  • receptive aphasia
  • hemispatial neglect or severe proprioceptive loss
  • significant illnesses
  • severe arthritis that limits arm and hand movements
  • a score of ≥1 on the NIHSS limb ataxia item

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Early Robotic/VR Therapy (EVR)
Subjects in this group will receive state-of-art inpatient usual care therapy plus 10 days of extra 1-hour/day of intensive therapy focusing on the hand using haptic robots integrated with complex gaming and virtual environments and initiated 5-30 days post stroke.
Device: Early Robotic/VR Therapy (EVR)
Subjects will perform state-of-art inpatient usual care therapy. In addition, they will perform an extra 1-hour/day of intensive therapy focusing on the hand in the form of interactive virtual reality games while assisted by robots. This additional treatment will be initiated 5-30 days post stroke.
Other Names:
  • NJIT-RAVR, NJIT-TrackGlove
Experimental: Delayed Robotic/VR Therapy (DVR)
Subjects in this group will receive state-of-art usual care therapy (inpatient and outpatient) plus 10 days of extra 1-hour/day of intensive therapy focusing on the hand using haptic robots integrated with complex gaming and virtual environments and initiated within 31-60 days post stroke.
Device: Delayed Robotic/VR Therapy (DVR)
Subjects will perform state-of-art inpatient usual care therapy. In addition, they will perform an extra 1-hour/day of intensive therapy focusing on the hand in the form of interactive virtual reality games while assisted by robots. This additional treatment will be initiated 31-60 days post stroke.
Other Names:
  • NJIT-RAVR, NJIT-TrackGlove
No Intervention: Usual Physical Therapy Care
Subjects in this group will receive state-of-art usual physical therapy/occupational therapy care.
Experimental: Dose-Matched Usual Physical Therapy Care
Subjects in this group will receive state-of-art usual physical therapy/occupational therapy care plus an extra hour of state-of-art usual care.
Behavioral: Dose-Matched Usual Physical Therapy Care
Subjects will perform state-of-art usual physical/occupational care and 10 days of one additional hour of state-of-art usual inpatient and/or outpatient physical therapy/occupational therapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Action Research Arm Test (ARAT)
Time Frame: 4 months post stroke
The ARAT assesses upper extremity activity. It is a 19 item test divided into four subscales: grasp, grip, pinch and movement. Scores range from 0-57 with higher scores indicating better performance.
4 months post stroke

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Action Research Arm Test
Time Frame: 6 months post stroke
The ARAT assesses upper extremity activity. It is a 19 item test divided into four
6 months post stroke
Action Research Arm Test
Time Frame: 1 month post treatment
The ARAT assesses upper extremity activity. It is a 19 item test divided into four
1 month post treatment
Action Research Arm Test
Time Frame: Immediately post treatment (ideally within 72 hours)
The ARAT assesses upper extremity activity. It is a 19 item test divided into four
Immediately post treatment (ideally within 72 hours)
Action Research Arm Test
Time Frame: Immediately prior to treatment (ideally within 72 hours)
The ARAT assesses upper extremity activity. It is a 19 item test divided into four
Immediately prior to treatment (ideally within 72 hours)
Cortical Area Representation of the Finger-Hand Muscles
Time Frame: 4 months post stroke
Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.
4 months post stroke
Cortical Area Representation of the Finger-Hand Muscles
Time Frame: 6 months post stroke
Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.
6 months post stroke
Cortical Area Representation of the Finger-Hand Muscles
Time Frame: 1 month post treatment
Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.
1 month post treatment
Cortical Area Representation of the Finger-Hand Muscles
Time Frame: Immediately post treatment (ideally within 72 hours)
Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.
Immediately post treatment (ideally within 72 hours)
Cortical Area Representation of the Finger-Hand Muscles
Time Frame: Immediately prior to treatment (ideally within 72 hours)
Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.
Immediately prior to treatment (ideally within 72 hours)
EEG-Based Measure of Resting State Brain Connectivity
Time Frame: 4 months post stroke
Electroencephalography will be used to evaluate resting-state brain connectivity.
4 months post stroke
EEG-Based Measure of Resting State Brain Connectivity
Time Frame: 6 months post stroke
Electroencephalography will be used to evaluate resting-state brain connectivity.
6 months post stroke
EEG-Based Measure of Resting State Brain Connectivity
Time Frame: 1 month post treatment
Electroencephalography will be used to evaluate resting-state brain connectivity.
1 month post treatment
EEG-Based Measure of Resting State Brain Connectivity
Time Frame: Immediately post treatment (ideally within 72 hours)
Electroencephalography will be used to evaluate resting-state brain connectivity.
Immediately post treatment (ideally within 72 hours)
EEG-Based Measure of Resting State Brain Connectivity
Time Frame: Immediately prior to treatment (ideally within 72 hours)
Electroencephalography will be used to evaluate resting-state brain connectivity.
Immediately prior to treatment (ideally within 72 hours)
EEG-Based Measure of Task-Based Brain Connectivity
Time Frame: 4 months post stroke
Task-based connectivity will be evaluated.
4 months post stroke
EEG-Based Measure of Task-Based Brain Connectivity
Time Frame: 6 months post stroke
Electroencephalography will be used to evaluate task-based brain connectivity.
6 months post stroke
EEG-Based Measure of Task-Based Brain Connectivity
Time Frame: 1 month post treatment
Electroencephalography will be used to evaluate task-based brain connectivity.
1 month post treatment
EEG-Based Measure of Task-Based Brain Connectivity
Time Frame: Immediately post treatment (ideally within 72 hours)
Electroencephalography will be used to evaluate task-based brain connectivity.
Immediately post treatment (ideally within 72 hours)
EEG-Based Measure of Task-Based Brain Connectivity
Time Frame: Immediately prior to treatment (ideally within 72 hours)
Electroencephalography will be used to evaluate task-based brain connectivity.
Immediately prior to treatment (ideally within 72 hours)
Cerebral Oxygenation in Sensorimotor Cortex
Time Frame: 4 months post stroke
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
4 months post stroke
Cerebral Oxygenation in Sensorimotor Cortex
Time Frame: 6 months post stroke
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
6 months post stroke
Cerebral Oxygenation in Sensorimotor Cortex
Time Frame: 1 month post treatment
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
1 month post treatment
Cerebral Oxygenation in Sensorimotor Cortex
Time Frame: Immediately post treatment (ideally within 72 hours)
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
Immediately post treatment (ideally within 72 hours)
Cerebral Oxygenation in Sensorimotor Cortex
Time Frame: Immediately prior to treatment (ideally within 72 hours)
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
Immediately prior to treatment (ideally within 72 hours)
Blocks and Box Test
Time Frame: 4 months post stroke
A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.
4 months post stroke
Blocks and Box Test
Time Frame: 6 months post stroke
A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.
6 months post stroke
Blocks and Box Test
Time Frame: 1 month post treatment
A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.
1 month post treatment
Blocks and Box Test
Time Frame: Immediately post treatment (ideally within 72 hours)
A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.
Immediately post treatment (ideally within 72 hours)
Blocks and Box Test
Time Frame: Immediately prior to treatment (ideally within 72 hours)
A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.
Immediately prior to treatment (ideally within 72 hours)
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
Time Frame: 4 months post stroke
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.
4 months post stroke
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
Time Frame: 6 months post stroke
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.
6 months post stroke
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
Time Frame: 1 month post treatment
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.
1 month post treatment
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
Time Frame: Immediately post treatment (ideally within 72 hours)
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.
Immediately post treatment (ideally within 72 hours)
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
Time Frame: Immediately prior to treatment (ideally within 72 hours)
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.
Immediately prior to treatment (ideally within 72 hours)
Wolf Motor Function Test
Time Frame: 4 months post stroke
A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.
4 months post stroke
Wolf Motor Function Test
Time Frame: 6 months post stroke
A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.
6 months post stroke
Wolf Motor Function Test
Time Frame: 1 month post treatment
A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.
1 month post treatment
Wolf Motor Function Test
Time Frame: Immediately post treatment (ideally within 72 hours)
A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.
Immediately post treatment (ideally within 72 hours)
Wolf Motor Function Test
Time Frame: Immediately prior to treatment (ideally within 72 hours)
A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.
Immediately prior to treatment (ideally within 72 hours)
Coordination between Hand Transport and Grasp during Reaching
Time Frame: 4 months post stroke
The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.
4 months post stroke
Coordination between Hand Transport and Grasp during Reaching
Time Frame: 6 months post stroke
The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.
6 months post stroke
Coordination between Hand Transport and Grasp during Reaching
Time Frame: 1 month post treatment
The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.
1 month post treatment
Coordination between Hand Transport and Grasp during Reaching
Time Frame: Immediately post treatment (ideally within 72 hours)
The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.
Immediately post treatment (ideally within 72 hours)
Coordination between Hand Transport and Grasp during Reaching
Time Frame: Immediately prior to treatment (ideally within 72 hours)
The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.
Immediately prior to treatment (ideally within 72 hours)
Arm Range of Motion
Time Frame: 4 months post stroke
Active range of motion for fingers, wrist, elbow and shoulder.
4 months post stroke
Arm Range of Motion
Time Frame: 6 months post stroke
Active range of motion for fingers, wrist, elbow and shoulder.
6 months post stroke
Arm Range of Motion
Time Frame: 1 month post treatment
Active range of motion for fingers, wrist, elbow and shoulder.
1 month post treatment
Arm Range of Motion
Time Frame: Immediately post treatment (ideally within 72 hours)
Active range of motion for fingers, wrist, elbow and shoulder.
Immediately post treatment (ideally within 72 hours)
Arm Range of Motion
Time Frame: Immediately prior to treatment (ideally within 72 hours)
Active range of motion for fingers, wrist, elbow and shoulder.
Immediately prior to treatment (ideally within 72 hours)
Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
Time Frame: 4 months post stroke
Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.
4 months post stroke
Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
Time Frame: 6 months post stroke
Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.
6 months post stroke
Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
Time Frame: 1 month post treatment
Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.
1 month post treatment
Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
Time Frame: Immediately post treatment (ideally within 72 hours)
Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.
Immediately post treatment (ideally within 72 hours)
Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
Time Frame: Immediately prior to treatment (ideally within 72 hours)
Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.
Immediately prior to treatment (ideally within 72 hours)
Maximum Thumb and Index Fingertip Pinch Force
Time Frame: 4 months post stroke
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
4 months post stroke
Maximum Thumb and Index Fingertip Pinch Force
Time Frame: 6 months post stroke
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
6 months post stroke
Maximum Thumb and Index Fingertip Pinch Force
Time Frame: 1 month post treatment
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
1 month post treatment
Maximum Thumb and Index Fingertip Pinch Force
Time Frame: Immediately post treatment (ideally within 72 hours)
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
Immediately post treatment (ideally within 72 hours)
Maximum Thumb and Index Fingertip Pinch Force
Time Frame: Immediately prior to treatment (ideally within 72 hours)
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
Immediately prior to treatment (ideally within 72 hours)
Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
Time Frame: 4 months post stroke
A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.
4 months post stroke
Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
Time Frame: 6 months post stroke
A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.
6 months post stroke
Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
Time Frame: 1 month post treatment
A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.
1 month post treatment
Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
Time Frame: Immediately post treatment (ideally within 72 hours)
A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.
Immediately post treatment (ideally within 72 hours)
Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
Time Frame: Immediately prior to treatment (ideally within 72 hours)
A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.
Immediately prior to treatment (ideally within 72 hours)
Measurement of Daily Use of Upper Extremity
Time Frame: 4 months post stroke
Wearable sensors will be used to quantify daily use of the affected arm after the intervention.
4 months post stroke
Measurement of Daily Use of Upper Extremity
Time Frame: 6 months post stroke
Wearable sensors will be used to quantify daily use of the affected arm after the intervention.
6 months post stroke
Measurement of Daily Use of Upper Extremity
Time Frame: 1 month post treatment
Wearable sensors will be used to quantify daily use of the affected arm after the intervention.
1 month post treatment
EuroQol
Time Frame: 4 months post stroke
The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.
4 months post stroke
EuroQol
Time Frame: 6 months post stroke
The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.
6 months post stroke
EuroQol
Time Frame: 1 month post treatment
The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.
1 month post treatment
EuroQol
Time Frame: Immediately post treatment (ideally within 72 hours)
The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.
Immediately post treatment (ideally within 72 hours)
EuroQol
Time Frame: Immediately prior to treatment (ideally within 72 hours)
The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.
Immediately prior to treatment (ideally within 72 hours)
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: 4 months post stroke
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.
4 months post stroke
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: 6 months post stroke
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.
6 months post stroke
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: 1 month post treatment
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.
1 month post treatment
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: Immediately post treatment (ideally within 72 hours)
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.
Immediately post treatment (ideally within 72 hours)
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: Immediately prior to treatment (ideally within 72 hours)
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.
Immediately prior to treatment (ideally within 72 hours)
Change in Robot-Based Measure of Elbow-Shoulder Coordination during Reaching
Time Frame: Day 1 and and Day 10 of treatment for EVR and DVR groups
To compare the immediate effects of training in the EVR and DVR groups, subjects will reach to five haptically rendered spheres located in a 3D virtual environment. The test will be performed every day immediately prior to VR training to measure changes in patterns of elbow-shoulder coordination.
Day 1 and and Day 10 of treatment for EVR and DVR groups
Change in Robot-Based Measure of Maximum Seated Workspace during Reaching
Time Frame: Day 1 and and Day 10 of treatment for EVR and DVR groups
To compare the immediate effects of training in the EVR and DVR groups, subjects will reach to five haptically rendered spheres located in a 3D virtual environment. The test will be performed every day immediately prior to VR training to measure changes in maximum seated workspace.
Day 1 and and Day 10 of treatment for EVR and DVR groups
Change in Robot-Based Measure of Movement Speed during Arm Reaching
Time Frame: Day 1 and and Day 10 of treatment for EVR and DVR groups
To compare the immediate effects of training in the EVR and DVR groups, subjects will reach to five haptically rendered spheres located in a 3D virtual environment. The test will be performed immediately prior to VR training to measure changes in arm speed during reaching for a virtual target.
Day 1 and and Day 10 of treatment for EVR and DVR groups
Change in Robot-Based Measure of Movement Speed during Targeted Finger Motion
Time Frame: Day 1 and and Day 10 of treatment for EVR and DVR groups
To compare the immediate effects of training in the EVR and DVR groups, subjects will perform targeted finger movements in a virtual environment. The test will be performed every day immediately prior to VR training to measure changes in the speed of finger movement towards a virtual target.
Day 1 and and Day 10 of treatment for EVR and DVR groups
Patient's Structured Subjective Assessment
Time Frame: Immediately post treatment (ideally within 72 hours) for EVR and DVR groups
This is a 27 item questionnaire that addresses the subjects perception of the function of their hemiplegic arm and the effect this intervention had on their hand function. Subjects fill out the questionnaire prior to and directly after the intervention. Some questions require a response such as disagree, neutral and agree, others require ordering their gaming activity preferences, or responding to a question with a short answer.
Immediately post treatment (ideally within 72 hours) for EVR and DVR groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
New Jersey Institute of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kessler Foundation
Rutgers University
Northeastern University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sergei V Adamovich, PhD, New Jersey Institute of Technology
  • Principal Investigator: Alma S Merians, PhD, PT, Rutgers University
  • Principal Investigator: Karen Nolan, PhD, Kessler Foundation
  • Principal Investigator: Eugene Tunik, PhD, PT, Northeastern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 24, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01HD058301 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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